Elagolix
As of the edition of 20 October 2026, Elagolix is a small molecule: marketed, first approved in 2018 (US); acts on GNRHR; US protection ends in 2039.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2018
- Kind
- Small molecule
- Brand name
- Orilissa
- First approved
- 23 July 2018 (US)
- Approvals on record
- 5 in 2 regions
- Holder of the most recent approval
- AbbVie
- Registered trials
- 33, 2 stopped early
- Disease areas
- Pregnancy and women's health; Urinary and reproductive; Cancer; Hormones; Heart and blood vessels; Injuries
US protection
US protection ends in 2039.
The last listed US drug-substance patent ends in 2039. The application that gives this date is held by AbbVie.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product6 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 6 listings behind itRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| GNRHR | Gonadotropin-releasing hormone receptor | P30968 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 1 | 0 | 0 |
| Phase 1 | 3 | 2 | 1 | 0 |
| Phase 2 | 9 | 9 | 0 | 0 |
| Phase 3 | 13 | 10 | 1 | 1 |
| Phase 4 | 6 | 2 | 2 | 1 |
| All trials | 33 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AbbVie | Originator and Lead sponsor of trials | 2006 to now |